Oral film of cftr modulator(s)

Abstract

The present invention provides oral film(s) of Cystic fibrosis transmembrane conductance regulator (CFTR) modulator(s) or a pharmaceutically acceptable salt thereof. Further the present invention provides composition and process for preparing oral film(s) comprising Cystic fibrosis transmembrane conductance regulator (CFTR) modulator(s) or a pharmaceutically acceptable salt thereof.

1 . An oral film of cystic fibrosis transmembrane conductance regulator (CFTR) modulator(s) and its pharmaceutically acceptable salts thereof. 
     
     
         2 . The oral film as claimed in  claim 1 , wherein the oral film comprises:
 i. cystic fibrosis transmembrane conductance regulator (CFTR) modulator(s) and its pharmaceutically acceptable salt thereof;   ii. at least one film forming polymer;   iii. plasticizer;   iv. optionally carrier(s); and   v. other pharmaceutically acceptable excipients.   
     
     
         3 . The oral film as claimed in  claim 1 , wherein the oral film comprises:
 i. Solid dispersion(s) of cystic fibrosis transmembrane conductance regulator (CFTR) modulator(s) and its pharmaceutically acceptable salt thereof;   ii. optionally another cystic fibrosis transmembrane conductance regulator (CFTR) modulator(s);   iii. at least one film forming polymer;   iv. plasticizer; and   v. other pharmaceutically acceptable excipients.   
     
     
         4 . The oral film as claimed in  claim 1 , wherein the cystic fibrosis transmembrane conductance regulator (CFTR) modulator is selected from Ivacaftor, Lumacaftor, Tezacaftor, Elexacaftor or combination of Ivacaftor/Lumacaftor, Ivacaftor/tezacaftor, Ivacaftor/tezacaftor/elexacaftor, or any other combinations and their pharmaceutically acceptable salts thereof. 
     
     
         5 . The oral film as claimed in  claim 2 , wherein the film forming polymer is selected from the group comprising of hydrophilic polymer(s) selected from hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, sodium carboxy methylcellulose, hydroxypropylmethylcellulose acetate succinate, polyvinyl pyrrolidone or povidone, copovidone, polydextrose, polyvinyl alcohol, polyvinyl acetate, polyethylene oxide, pullulan, sodium alginate, propylene glycol alginate, polyacrylic acid, copolymers of acrylic acid, carboxyvinyl copolymers, modified starch, gelatin, pectin, hydroxypropylethylcellulose, polyoxyethylene stearates, poly-epsilon caprolactone, polyglycolized glycerides, cyclodextrins, carrageenan, galactomannans, polymerized rosin and combinations thereof and/or hydrophobic polymer(s) selected from ethyl cellulose, cellulose acetate, butyl cellulose, polymethacrylates, shellac, stearic acid, glyceryl behenate, palmitic acid and combinations thereof. 
     
     
         6 . The oral film as claimed in  claim 2 , wherein the plasticizer is selected from the group comprising of polyethylene glycol, propylene glycol, polyethylene-propylene glycol, glycerol, glycerol monoacetate, diacetate or triacetate, triacetin, polysorbate, cetyl alcohol, sorbitol, sodium diethylsulfosuccinate, triethyl citrate, tributyl citrate, phthalate derivatives such as dimethyl, diethyl and dibutyl phthalate and combinations thereof. 
     
     
         7 . The oral film as claimed in  claim 2 , wherein the carrier is selected from the group comprising of povidone, copovidone, polyvinyl alcohol, cellulose derivatives including hydroxypropylmethylcellulose acetate succinate, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft co-polymer, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, hydroxyethyl cellulose, hydroxypropylmethylcellulose phthalate, polymethacrylic polymers, polyethylene glycol, polyoxyethylene oxide, poloxamers, polyoxyethylene stearates, poly-epsilon caprolactone, polyglycolized glycerides, pectins, cyclodextrins, galactomannans, dextrin, mannitol, alginates, carragenan, xanthan gum and combinations thereof. 
     
     
         8 . The oral film as claimed in  claim 2 , wherein other pharmaceutically acceptable excipients are selected from the group comprising of suspending/thickening agents, disintegrating agents, fillers/bulking agents, stabilizers, surfactants, sweetening agents, taste masking agents, anti-foaming agents, flavoring agents, coloring agents and combinations thereof. 
     
     
         9 . The oral film as claimed in  claim 1 , wherein the composition comprises:
 i. from about 5% to about 75% by weight of cystic fibrosis transmembrane conductance regulator (CFTR) modulator or combinations of cystic fibrosis transmembrane conductance regulator (CFTR) modulators and its pharmaceutically acceptable salts;   ii. from about 1% to about 60% by weight of at least one film forming polymer;   iii. from about 1% to about 15% by weight of plasticizer;   iv. from 0% to about 50% by weight of carrier(s); and   v. other pharmaceutically acceptable excipients.   
       wherein the percentage by weight is relative to the total weight of the composition. 
     
     
         10 . The oral film as claimed in  claim 1 , wherein the composition comprises:
 i. from about 20% to about 95% by weight of solid dispersion(s) of cystic fibrosis transmembrane conductance regulator (CFTR) modulator(s) and its pharmaceutically acceptable salts;   ii. from about 1% to about 60% by weight of at least one film forming polymer;   iii. from about 1% to about 15% by weight of plasticizer; and   iv. other pharmaceutically acceptable excipients.   
       wherein the percentage by weight is relative to the total weight of the composition.